HypnosisPreVRNCT06502457
Pain Management With Virtual Reality Hypnosis
A study testing painkiller and hypnosis group in people with Hypnosis and Labor Pain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
Trial summary
The latency phase corresponds to the first phase of the first stage of labour, during which the parturient feels regular, rhythmic uterine contractions that are often painful, with or without changes of the cervix. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hypnosis, Labor Pain, Virtual Reality
- What is being tested?
- painkiller and hypnosis group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 142 participants
- Where
- 1 siteFrance
- Study dates
- 9 Jul 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Parturient over 18
- Parturient who speaks and understands French
- Parturient hospitalised prior to labour
- Membranes intact or ruptured
- Spontaneous or induced labour
- Parturient in latency phase
Show all 10Show fewer
- Term ≥ 37SA
- END > 3
- Parturient requiring active pain management (medicinal or non-medicinal)
- Low-risk pregnancy
Who cannot join
- Parturient under legal protection
- Parturient with a hearing impairment
- Parturient with visual impairment
- Parturient with epilepsy
- Parturient with psychiatric problems
- Pathological pregnancy
Show all 13Show fewer
- Parturient with chronic pain
- Parturient with addiction-related disorders
- Parturient allergic to paracetamol
- Parturient allergic to phloroglucinol
- Parturient allergic to codeine
- Parturient allergic to nalbuphine
- Parturient allergic to orozamudol
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU Amiens Picardie
Amiens
Julien VARGAS, MD, 0322088281, Vargas.julien@chu-amiens.fr
About this study
Official title: Pain Management With Virtual Reality Hypnosis in Parturients in the Latency or Cervical Ripening Phase
The latency phase corresponds to the first phase of the first stage of labour, during which the parturient feels regular, rhythmic uterine contractions that are often painful, with or without changes of the cervix. This phase lasts an average of 8 hours for primiparous women, compared with 5 hours for multiparous women, and can last up to twenty hours in total.
Cervical ripening corresponds to the medical induction of regular, painful uterine contractions in order to obtain a favourable cervix for the induction of labour. Cervical ripening is carried out either medically (oral or local prostaglandins) or mechanically (double balloon dilatation) and accounts for 69.2% of labour inductions, which in turn account for 25.8% of births.
Read more
At Amiens-Picardie University Hospital, this maturation stage can last from a few hours to 2 days, depending on the service protocol.
What these two stages of childbirth have in common is that they are both painful, with very few analgesic drugs available that can be used without side-effects on the foetus during pregnancy.
In recent years, there has also been a growing demand from parturients for the use of non-medicinal therapies.
It therefore seems essential to provide parturients with as many effective non-drug methods as possible to manage their pain properly.
If virtual reality hypnosis sessions prove to be effective, they will provide better pain management for women in labour, reduce the use of morphine derivatives (with their attendant side-effects, particularly on the foetus), and above all meet the growing demand from women in labour for the most physiological possible support during childbirth.
- Conditions
- Hypnosis, Labor Pain, Virtual Reality, Labor Induction, Latent Period
- Being tested
- painkiller, hypnosis group
- Keywords
- hypnosis, labor pain, virtual reality, labor induction, latent period
- Medical subject headings
- Labor Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
painkillerDrug
The control group will receive a painkiller adapted to the service protocol after the fetal heart rate has been recorded.
hypnosis groupOther
The hypnosis group will receive a hypnosis session after the fetal heart rate has been recorded. Automated measurement of blood pressure and maternal heart rate will take place during the session in order to objectively assess the impact of the session on the mother.
Patients in the hypnosis group will then have access to the virtual reality headset on request throughout the latency or maturation phase, and will also be able to benefit from a painkiller in accordance with the service protocol if they so request.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Not described Receives: Drug: painkiller |
| hypnosis group | Experimental | Not described Receives: Other: hypnosis group |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain intensity difference between the first analgesic procedure and 30min later
Assessment of PID (pain intensity difference) between the first analgesic procedure and 30min later.
Measured: 30 minutes
Secondary outcomes (1)
Average consumption of analgesics
Average consumption of analgesics (morphine agonists and other analgesics) during the latency or maturation period.
Measured: 12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2024
- Study start9 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypnosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier Universitaire, Amiens
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06502457
- Sponsor's protocol ID
- PI2024_843_0067
- Acronym
- PreVR
- Status last verified
- May 2025
- First submitted
- 9 Jul 2024
- Last updated
- 25 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pain Management With Virtual Reality Hypnosis in Parturients in the Latency or Cervical Ripening Phase
- ClinicalTrials.gov ID
- NCT06502457
- Acronym / sponsor ID
- PreVR / PI2024_843_0067
- Conditions
- Hypnosis, Labor Pain, Virtual Reality, Labor Induction, Latent Period
- Keywords
- hypnosis, labor pain, virtual reality, labor induction, latent period
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Centre Hospitalier Universitaire, AmiensUniversity, hospital or other
- Study start
- 9 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 16 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The latency phase corresponds to the first phase of the first stage of labour, during which the parturient feels regular, rhythmic uterine contractions that are often painful, with or without changes of the cervix. This phase lasts an average of 8 hours for primiparous women, compared with 5 hours for multiparous women, and can last up to twenty hours in total.
Cervical ripening corresponds to the medical induction of regular, painful uterine contractions in order to obtain a favourable cervix for the induction of labour. Cervical ripening is carried out either medically (oral or local prostaglandins) or mechanically (double balloon dilatation) and accounts for 69.2% of labour inductions, which in turn account for 25.8% of births.
At Amiens-Picardie University Hospital, this maturation stage can last from a few hours to 2 days, depending on the service protocol.
What these two stages of childbirth have in common is that they are both painful, with very few analgesic drugs available that can be used without side-effects on the foetus during pregnancy.
In recent years, there has also been a growing demand from parturients for the use of non-medicinal therapies.
It therefore seems essential to provide parturients with as many effective non-drug methods as possible to manage their pain properly.
If virtual reality hypnosis sessions prove to be effective, they will provide better pain management for women in labour, reduce the use of morphine derivatives (with their attendant side-effects, particularly on the foetus), and above all meet the growing demand from women in labour for the most physiological possible support during childbirth.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Drug: painkiller |
| hypnosis group | Experimental | Other: hypnosis group |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Parturient over 18
- Parturient who speaks and understands French
- Parturient hospitalised prior to labour
- Membranes intact or ruptured
- Spontaneous or induced labour
Key exclusion criteria (13 listed)
- Parturient under legal protection
- Parturient with a hearing impairment
- Parturient with visual impairment
- Parturient with epilepsy
- Parturient with psychiatric problems
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| painkillerThe control group will receive a painkiller adapted to the service protocol after the fetal heart rate has been recorded. | Drug | control group |
| hypnosis groupThe hypnosis group will receive a hypnosis session after the fetal heart rate has been recorded. Automated measurement of blood pressure and maternal heart rate will take place during the session in order to objectively assess the impact of the session on the mother. Patients in the hypnosis group will then have access to the virtual reality headset on request throughout the latency or maturation phase, and will also be able to benefit from a painkiller in accordance with the service protocol if they so request. | Other | hypnosis group |
Primary outcome
pain intensity difference between the first analgesic procedure and 30min later
Time frame: 30 minutes
Assessment of PID (pain intensity difference) between the first analgesic procedure and 30min later.
1 secondary outcome
Average consumption of analgesics
Time frame: 12 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing painkiller and hypnosis group in people with Hypnosis and Labor Pain, run by Centre Hospitalier Universitaire, Amiens at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 25 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
pain intensity difference between the first analgesic procedure and 30min later (time frame: 30 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2025.